Table of Contents
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Table of Contents
Summary of Contents for SBM IDRA
- Page 1 IDRA User Manual...
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Page 2: Table Of Contents
INDEX INTRODUCTION SYMBOLS CARES, WARNINGS AND GENERAL SAFETY ADVICES Ordinary maintenance Transport, storage conditions and terms of use THE INSTRUMENT Spare parts Accessories Supply package SOFTWARE ICP USER MANUAL Software installation First use GUIDE OF USE Functional features MAIN USE HOME SCREEN Create a new patient New exam... -
Page 3: Introduction
Thank you for purchasing the IDRA of SBM Sistemi S.r.l. All our products have been manufactured with the greatest attention to safety. The IDRA, code 15011, is a high-performance instrument. To use efficiently and safely the instrument, please read carefully this manual before installing and using the instrument and follow all warnings in it and outside the equipment. -
Page 4: Symbols
Device number reference Device serial number Handle with care / Upward Fragile Transport and storage conditions (temperature / humidity / pressure) © 2018 SBM Sistemi S.r.l. All rights reserved. All other products and company names are trademarks of their respective owners. -
Page 5: Cares, Warnings And General Safety Advices
CARES, WARNINGS AND GENERAL SAFETY ADVICES Created and developed 100% in Italy. Medical device IDRA registered in Class I at the Ministry of Health according to Directive EN 60601- 1. Risk class: A. The product subject of this manual is a medical device according to Directive 93/42/ECC and subsequent amendments. -
Page 6: Transport, Storage Conditions And Terms Of Use
Transport, storage conditions and terms of use The instrument in its original packaging, may be exposed to the following environmental conditions without being damaged, for a maximum period of 15 weeks during shipment and storage: • Temperature between -10 ° C and +60 ° C; •... -
Page 7: Accessories
Accessories The purchase of IDRA provides for the availability of various accessories, the use of them is essential or recommended. Between these: • A cone with placid disc • Foot pedal to record videos/take pictures • IDRA support applicable to the working table • Suitcase to store the device to protect and transport it... -
Page 8: Software Icp User Manual
SOFTWARE USER MANUAL SOFTWARE INSTALLATION The installation and configuration process of IDRA Software consist of the installation of the software files through the Setup provided by the supplier. 1. Execute Setup file 2. Start the software to download the ICP application on the PC. - Page 9 You must be connected to internet in order to activate the application. • If you do not have an ID and password of SBM Sistemi Account you must tap “New Registration”, fill in all the fields and tap the “Send” button. Once you make your new registration is important KEEP your ID and PASSWORD chosen in the above procedure, in order to activate other applications available from supplier.
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Page 10: First Use
The IDRA must be kept as close as possible to the eye without touching. Closer is the device to the eye, broader is the area lighted by the instrument. The light reflected from the tear film can be observed as a white circular area that almost completely covers the cornea. -
Page 11: Main Use
Gradation is not accurate when there are reflected tears. IDRA’s brightness is calibrated so as not to cause any glare in the patient examined; besides, the light being cold it does not induce excessive reflected lachrymation. -
Page 12: Home Screen
On the bottom it is possible to look at general and specific information of the selected patient. A) It provides to consult the patient’s condition based on the exams done. B) It allows you to watch the summary of the values saved after having done the exams with the IDRA (“Dry Eye”). -
Page 13: New Exam
Tapping “New Exam” button on the top, it is possible to start a new screening exam for the patient choose. Please choose a patient before proceeding with a new exam creation. In this section will be highlighted the IDRA interface that will allow you to make different main exams: • Interferometry • Tear Meniscus... -
Page 14: Main Exams
MAIN EXAMS Interferometry (Fig. 7) Using the images capture screen, record a video of the patient’s eye with the main cone inserted in the instrument and asking to blink three-four times to the patient. To record a good video, go on focus on the iris moving the base and then move backward of 2mm to focus properly on the LIPID LAYER (the iris will be not on focus). -
Page 15: Additional Examinations
Exam”, it’s possible to take a picture with white lights by focusing on the eyelashes and the eyelid rhyme. To take it, IDRA executes a magnification that allows to study in a perfect way the situation. The results can be compared with the right grading... -
Page 16: Pupillometry
Corneal deformation IDRA can also be used to assess the regularity of the corneal profile. By inserting the specific cone inside the instrument, a series of concentric rings is projected onto the cornea. If the corneal surface is regular, the concentric rings will all be at the same distance. - Page 17 Follow strictly the instructions on the left side of the screen. 1) The acquisition will automatically start simulating SCOTOPIC light. It is necessary to ask the patient to look inside the device, to focus four bright spots and center them with the reference circle (fig. 15 b). Then, acquire the image through space bar or foot pedal.
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Page 18: Generic Exam
This test allows to measure the horizontal iris diameter from white to white (white to white). Unlike pupillometry, this value remains constant over time. Follow the instructions given in the “Pupillometry” section in point 1. GENERIC EXAM This option allows to use the device such as a digital slit lamp to study the anterior ocular segment. It is possible to record videos, take pictures and choose the kind of lighting. -
Page 19: Exams List
EXAMS LIST Display exams related to a patient The exams saved list will be shown at the end of an exam or in the “Exams” section. In this section it is also possible to edit and compare the exams through the selection of the chosen exam. Fig. -
Page 20: Buttons
Fig. 18 Modify button Let you add a note related to the selected exam. In this way, the change will appear on PDF of the exam when you will save it. Compare Button Let you compare the selected image or video with: • Images/videos of the same patient, • Images/video of other patients, • International grading scales (CCLRU, Efron, Jenvis and Meibography). -
Page 21: Troubleshooting
Photo Button The “Photo” white button take and save a picture of the subject. Video Button Tap “Video” red button to start a video recording of the subject and tap again to stop and save it. Select Eye Button Tap it to choose or change eye. Screenshot Button It allows to do a screenshot from a selected frame in a video to save this image. -
Page 22: Minimum Hardware Requirements
Working distance 2 cm - 6 cm by ocular surface Output USB 2.0 e USB 3.0 (B connector) Electromagnetic Compatibility (EMC) IEC 60601-1-2 (2015) Supply Voltage Device Operating Voltage Dimensions 167,7 mm (L) x 226 mm (H) x 40 mm (P) Weight 500 gr. -
Page 23: Radiated Emission Peak
Radiated emission peak... -
Page 24: Immunity Test
Immunity test Tests done on both versions Immunity for electrostatic discharge (ESD) Reference document: EN 61000-4-2 Level: ±15KV (air), ± 8KV (contact) Test Equipment: Schaffner NSG 435 Environmental Conditions: Temperature: 20°C, RH: 40% Uncertainty: ±5% Test Points Number of Discharges Discharge Voltage (KV) Reference Standard Enclosure... -
Page 25: Immunity To Rf Wireless Communication Equipment
Immunity to rf wireless communication equipment Reference document: EN 61000-4-3 Test level: see table below Test Equipment: Generator: Rhode & Schwarz SM300; Amplifier: Kalmus 737FC; Frankonia Amplifier FLG30C; Log- periodic antenna Frankonia BTA-M; Management software Frankonia; Isotropic sensor PMM EP 330 Temperature 20°C, RH 40% Environmental Conditions: Uncertainty:... -
Page 26: Power Frequency Magnetic Fields Immunity Test
Power frequency magnetic fields immunity test Reference document: EN 61000-4-8 Level: EN 60601-1-2 Test Equipment: Generator PMM DAS-G120, Coil DANA DAS S120 Environmental Conditions: Temperature: 20°C, RH: 40% Uncertainty: <8% Port Range freq. (Hz) Level (A/m) Reference Standard Enclosure EN 60601-1-2 SUMMARY OF TESTS RESULTS The following table summarizes the tests performed: Frequency range... -
Page 27: Settings
SETTINGS In this section, you can access all settings data concerning photos and videos (video compression, video cutoff, image quality), you can create sample exams, set the address of your office/hospital/company and choose the exams path saved on your PC. Moreover it is possible to choose the language. - Page 28 Database allows to choose who can use the same database. To use ICP as a viewer to open a database located on the local network, please read “Using ICP as a Viewer” section below. Instruments section gives you technical information of the hardware. “Company”...
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Page 29: Using Icp As A Viewer
USING ICP AS A VIEWER Mapping network drive To use ICP as a viewer to open a database located on the local network the first step is to Map a network drive on the computer where the viewer is installed. This drive will be usually named like “Z:” or another letter that will be linked to the network shared folder containing the database of ICP. -
Page 30: Disposal Policy
Severe administrative sanctions available under the law in force for offenders. LIABILITY SBM SISTEMI S.r.l. is responsible for compliance to EU Directive 93/42 / EEC, also to its performance, safety and reliability. SBM SISTEMI S.r.l. specifies that all components of the equipment of its production are insured and fully guaranteed for 12 (twelve) months. -
Page 31: Warranty And Contacts
WARRANTY AND CONTACTS SBM SISTEMI S.r.l. guarantees the product for a period of 12 months from the date of billing. The warranty covers the replacement from SBM SISTEMI S.r.l. of components and materials, and its workforce. The shipping and transportation are charged to the customer. - Page 32 www.sbmsistemi.com Strada Torino, 43 - 10043 Orbassano (Torino) Italy Tel. +39.011.19923378 - info@sbmsistemi.com...
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